Events

Recall of ISE Reference Solenoid Valve for AU400, AU480, AU640, AU680, AU2700, AU5400 and AU5800 Chemistry Analysers. An in vitro diagnostic medical device (IVD)(clinical chemistry analysers)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Beckman Coulter Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2013-RN-01012-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-10-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01012-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Beckman coulter has confirmed that some ise units can experience premature ise ref (reference) valve failure. premature valve failure can be detected by the presence of air bubbles in the ise ref solution tubing on the ise unit. if air bubbles are present, accuracy of the ise test results may be affected. affected results may be clinically significant (high or low) and may impact patient diagnosis and/or treatment.
  • Action
    Beckman Coulter is providing users with instructions on how to inspect tubing for the presence of air bubbles. Where air bubbles are present, users are to contact Beckman Coulter for a replacement valve. Beckman Coulter is recommending consulting the laboratory director to determine the impact of this issue and if a retrospective review of prior results is necessary. As a preventative measure, Beckman Coulter is proving work around instructions for users to follow until a replacement ISE valve is implemented.

Device

ISE Reference Solenoid Valve for AU400, AU480, AU640, AU680, AU2700, AU5400 and AU5800 Chemistry ...

Manufacturer

Beckman Coulter Australia Pty Ltd